Purpose: Evaluate the efficacy and safety of CANA 100 mg and 300 mg compared with placebo (PBO) as add on to incretin-based therapy. Methods: Post-hoc analyses of data from the CANagliflozin cardioVascular Assessment Study (CANVAS) evaluated CANA 100 mg and 300 mg vs. PBO in subsets of subjects on DPP-4i (n=316; mean age 63 years; A1C 8.1%; BMI 32.3) or GLP-1 agonists (n=95; mean age 61 years; A1C 8.1%; BMI 37.4) as monotherapy or in combination with other AHAs. Results: At week 18, CANA 100 and 300 mg reduced A1C and weight relative to PBO in both subsets (Table). Adverse event (AE) rates were higher with CANA than with PBO in the DPP-4i subset, comparable or lower with CANA relative to PBO in the GLP-1 agonist subset; serious AE rates were generally higher with CANA than PBO in both subsets. Documented hypoglycemia rates were higher with CANA 100 mg and 300 mg than PBO in subjects on insulin, sulfonylurea or meglitinide in the DPP-4i subset (17/70, 29/87 and 12/74) and the GLP-1 agonist subset (11/29, 11/22 and 4/26); only 2 and 1 CANA-treated subjects not on these concomitant agents reported hypoglycemia in the DPP-4i and GLP-1 agonist subsets, respectively. Summary: In these post-hoc analyses, CANA added on to DPP-4i or GLP-1 agonists(+/e other AHAs) lowered A1C, reduced body weight and was generally well tolerated in subjects with T2DM at 18 weeks. (Table Presented) .
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